The device treats coronary artery perforation by providing a physical barrier to seal a tear while allowing blood to flow to the heart muscle.

The Food and Drug Administration (FDA) has approved the PK Papyrus Covered Coronary Stent System (Biotronik) for the treatment of acute coronary artery perforations, the first device approved for this indication in 17 years.

The PK Papyrus Stent System is a balloon-expandable covered coronary stent and delivery system. Using a balloon catheter, the device is implanted into the torn coronary artery vessel. Once the stent is placed, it acts as a physical barrier to seal the perforation while allowing blood to flow through the device to the heart. Sealing of the coronary tear with the stent system can be life-saving and eliminate the need for open-heart surgery.

The device was reviewed through the Agency’s Humanitarian Use Device exemption process, designed for devices that are intended to benefit ≤8000 patients per year in the US. The Agency reviewed real-world data from 80 patients who received the PK Papyrus Stents in percutaneous coronary intervention (PCI) procedures and found that the stents were delivered successfully to the perforation site in 76 patients (95%) and sealed the perforation in 73 patients (91.3%).

Regarding safety, 2 deaths occurred during the PCI procedure, and 7 patients underwent treatment to drain a fluid collection around the heart. Post-procedure, there were 5 in-hospital deaths reported with perforations successfully sealed by PK Papyrus Stents, and 1 patient in which the Papyrus Stent did not successfully seal the perforation.

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Director of the Division of Cardiovascular Devices at the FDA, Bram Zuckerman, MD, said, “The PK Papyrus Covered Coronary Stent System provides health care providers with a new treatment option that can seal the perforation in order to stop blood leakage during the procedure and avoid a potentially life-threatening complication or a more invasive surgical procedure.”

The device should not be used in patients who are not candidates for standard PCI procedures. Also, it is contraindicated for patients with a known allergy or hypersensitivity to amorphous silicon carbide or any other compound of the PK Papyrus stent (Siloxane-based Polyurethane, L-605, and cobalt chromium alloy, including tungsten and nickel).